Dicyclomine + Magnesium Trisilicate + Mefenamic Acid

Usage

This combination medication is primarily prescribed for the symptomatic relief of gastrointestinal spasms, pain, and cramps. It is commonly used for conditions such as irritable bowel syndrome (IBS), biliary colic, dysmenorrhea (menstrual cramps), and other functional bowel disorders.

• Pharmacological Classification: This is a combination product containing an anticholinergic (dicyclomine), an antacid (magnesium trisilicate), and a non-steroidal anti-inflammatory drug (NSAID) (mefenamic acid).

• Mechanism of Action: Dicyclomine relaxes smooth muscles in the gastrointestinal tract. Magnesium trisilicate neutralizes gastric acid, offering relief from heartburn and indigestion. Mefenamic acid reduces pain and inflammation.

Alternate Names

This combination medication doesn’t have an internationally recognized non-proprietary name. It’s frequently identified by brand names, which can differ based on the manufacturer and region. One example is “Sispas Tablet”. Always verify the active ingredients to ensure accurate dispensing.

How It Works

• Pharmacodynamics: Dicyclomine works by blocking acetylcholine at muscarinic receptors, leading to smooth muscle relaxation in the GI tract. Magnesium trisilicate neutralizes stomach acid, providing relief from acidity. Mefenamic acid inhibits cyclooxygenase (COX) enzymes, thus reducing prostaglandin production and relieving pain and inflammation.

• Pharmacokinetics: The components have varying pharmacokinetic profiles. Dicyclomine is metabolized in the liver. Mefenamic acid undergoes extensive metabolism, mainly excreted in urine. Magnesium trisilicate is not systemically absorbed.

• Mode of Action: Dicyclomine exerts antimuscarinic activity on M1, M3, and M2 receptors, also antagonizing bradykinin and histamine. Magnesium trisilicate directly neutralizes stomach acid. Mefenamic acid inhibits COX enzymes.

• Elimination Pathways: Dicyclomine is primarily eliminated through hepatic metabolism. Mefenamic acid undergoes hepatic metabolism and renal excretion.

Dosage

Standard Dosage

Adults: One to two tablets or capsules three to four times a day is typical. The maximum daily dose shouldn’t be exceeded without medical supervision.

Children: This combination is generally not recommended for children under 12. Dosing for older children must be determined by a physician, based on weight and condition.

Special Cases:

• Elderly Patients: Lower initial doses are advisable, with careful titration due to decreased renal and hepatic function.
• Patients with Renal Impairment: Dose reduction is necessary in moderate to severe renal impairment.
• Patients with Hepatic Dysfunction: Dose adjustments may be necessary. Close monitoring is recommended.
• Patients with Comorbid Conditions: Close monitoring is necessary, especially with cardiovascular disease or other relevant conditions.

Clinical Use Cases

The specific fixed-dose combination of Dicyclomine + Magnesium Trisilicate + Mefenamic Acid is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. The individual components might be used in certain perioperative or critical care settings, but not this specific fixed-dose combination.

Dosage Adjustments

Adjustments are crucial for patients with renal/hepatic dysfunction, metabolic disorders, or genetic polymorphisms. Close monitoring and adjustments based on clinical presentation are recommended.

Side Effects

Common Side Effects:

Dry mouth, blurred vision, constipation, drowsiness, dizziness, nausea, vomiting, and weakness.

Rare but Serious Side Effects:

Allergic reactions (anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis), gastrointestinal bleeding, peptic ulcers.

Long-Term Effects:

Chronic NSAID use can increase risks of gastrointestinal issues and kidney problems. Long-term anticholinergic use may lead to cognitive impairment.

Adverse Drug Reactions (ADR):

Anaphylaxis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis require immediate medical intervention.

Contraindications

• Absolute Contraindications: Hypersensitivity to components, paralytic ileus, severe ulcerative colitis, toxic megacolon, myasthenia gravis, closed-angle glaucoma, urinary retention, severe liver or kidney disease, active gastrointestinal bleeding.
• Relative Contraindications: Prostatic hyperplasia, cardiovascular disease, hepatic or renal impairment, history of gastrointestinal disorders, asthma.

Drug Interactions

• Clinically Significant Drug Interactions: Other anticholinergics, antacids, anticoagulants, some antidepressants, pain killers (aspirin), diuretics, anti-psychotics, anti-rheumatoid drugs, blood thinners, cardiac glycosides, anti-diabetic medications, antibiotics, anti-platelet drugs, steroids, immunosuppressants, anti-HIV medications, and anti-emetic medications.

• CYP450 Interactions: Mefenamic acid interacts with drugs metabolized by CYP enzymes.

Pregnancy and Breastfeeding

• Pregnancy Safety Category: Mefenamic acid is contraindicated during the third trimester. Dicyclomine should be used cautiously throughout pregnancy. Consult a physician before use.
• Breastfeeding: This combination’s safety during breastfeeding is not established. It is recommended to avoid use or discontinue breastfeeding if necessary.

Drug Profile Summary

• Mechanism of Action: Dicyclomine (anticholinergic) relaxes GI smooth muscles, magnesium trisilicate neutralizes gastric acid, and mefenamic acid (NSAID) provides analgesic and anti-inflammatory effects.
• Side Effects: Dry mouth, blurred vision, constipation, drowsiness, dizziness, nausea, vomiting, and weakness. Serious side effects include allergic reactions and gastrointestinal bleeding.
• Contraindications: Hypersensitivity, paralytic ileus, glaucoma, urinary retention, severe liver or kidney disease, active gastrointestinal bleeding.
• Drug Interactions: Other anticholinergics, antacids, anticoagulants, and some antidepressants.
• Pregnancy & Breastfeeding: Avoid if pregnant or breastfeeding. Mefenamic acid is contraindicated in the third trimester.
• Dosage: Adults: one to two tablets three to four times daily. Adjustments needed for special populations.
• Monitoring Parameters: Monitor renal and hepatic function, especially in elderly and those with impairment. Observe for signs of gastrointestinal bleeding and allergic reactions.

Popular Combinations

This combination is itself a fixed-dose combination.

Precautions

• General Precautions: Screening for allergies, metabolic disorders, and organ dysfunction is recommended.
• Pregnant Women: Use with caution. Mefenamic acid is contraindicated in the third trimester.
• Breastfeeding Mothers: Avoid or discontinue breastfeeding.
• Children & Elderly: Not generally recommended for children under 12. Lower initial dose for elderly patients.
• Lifestyle Considerations: Avoid alcohol while taking this medication as it may increase drowsiness and risk of stomach bleeding. Caution with driving due to potential drowsiness and dizziness.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Dicyclomine + Magnesium Trisilicate + Mefenamic Acid?

A: Adults typically take one to two tablets or capsules three to four times a day. Pediatric use is generally not recommended, especially under 12. Dosage adjustments are required for patients with renal or hepatic impairment and elderly patients.

Q2: What are the primary uses of this combination medication?

A: It is used to relieve gastrointestinal spasms and pain associated with conditions such as IBS, biliary colic, and dysmenorrhea.

Q3: What are the common side effects?

A: Common side effects include dry mouth, blurred vision, constipation, drowsiness, dizziness, nausea, vomiting, and weakness.

Q4: What are the serious side effects I should watch out for?

A: Serious side effects include allergic reactions (anaphylaxis, Stevens-Johnson syndrome), gastrointestinal bleeding, and peptic ulcers. Seek immediate medical attention if these occur.

Q5: Can pregnant or breastfeeding women take this medicine?

A: Mefenamic acid is contraindicated in the third trimester of pregnancy. Dicyclomine should be used with caution during pregnancy. This combination is generally avoided during breastfeeding. Consult a physician before use.

Q6: What are the contraindications for this medication?

A: It’s contraindicated in hypersensitivity to any component, paralytic ileus, severe ulcerative colitis, glaucoma, urinary retention, severe liver or kidney disease, and active gastrointestinal bleeding.

Q7: Does this medication interact with other drugs?

A: Yes, it can interact with other anticholinergics, antacids, anticoagulants, and some antidepressants. It can also interact with various other medications, including certain pain killers, diuretics, and antibiotics. Always inform your doctor about all medications you are taking.

Q8: Are there any specific precautions for elderly patients?

A: Elderly patients should start with a lower dose due to decreased renal and hepatic function. Close monitoring for side effects is essential.

Q9: Can I drive while taking this medication?

A: Use caution while driving or operating machinery as this medication may cause drowsiness and dizziness.

Q10: How should this medication be stored?

A: Store at room temperature as per the manufacturer’s instructions.